Acute respiratory distress syndrome (ARDS) is a major public health problem, accounting for 23% of intubated patients and associated with high mortality rates. Although lifesaving, invasive mechanical ventilation can worsen lung injury when ventilator settings are poorly adjusted to lung physiology. We hypothesise that individualising ventilator settings via (1) the bedside assessment of lung recruitability using a one-breath derecruitment manoeuvre and measurement of airway opening pressure to set positive end-expiratory pressure (PEEP), (2) controlling the distending pressure and (3) controlling respiratory drive improves ARDS outcomes.

The CAreful Ventilation In ARDS trial is an investigator-led multicentre (33 centres in eight countries), open-label, randomised controlled basket trial comparing two ventilation strategies in two subpopulations of moderate-to-severe ARDS: induced or not by COVID-19. A total of 740 patients will be randomised (370 in each substudy) in a 1:1 ratio to individualised ventilator settings or to using traditional PEEP to inspired fraction of oxygen tables for PEEP setting. Indications for proning and weaning strategies are similar in both arms. The primary outcome is all-cause mortality at day 60. Secondary outcomes include duration of mechanical ventilation, duration of intensive care unit (ICU) and hospital stay, organ dysfunction, barotrauma and mortality in ICU, at day 28 and in hospital.

Ethics approval has been obtained for all participating centres: Unity Health Toronto Research Ethics Board (for three centres: St Michael’s Hospital, Toronto General Hospital and Toronto Western Hospital); Comité de Ética de Investigación con Medicamentos del Hospital Universitari Vall d’Hebron; Comité de protection des personnes Ile de France III; Comité d'Ética de la Investigatción con Medicamentos de la Fundació de Gestió Sanitària del Hospital de la Santa Creu i Sant Pau; Comitato Etico—Fondazione Policlinico Gemelli; Comitato Etico di Area Vasta Emilia Centro; NYU Langone Health Institutional Review Board; Comité Ético Científico de Ciencias de la Salud; Il Comitato Etico Area 1 dell’Azienda Ospedaliero-Universitaria ‘Ospedali Riuniti’ di Foggia; HIGA ‘Eva Perón’ Comité de Bioética; Comité de Revisión Institucional del Hospital Británico Comité de Ética en Investigación; Complejo Médico Churruca-Visca Comité de Ética Biomédica; Comité de Ética SATI Comité de Ética en Investigación; Comité de Ética en Investigación del CEMIC; Comité de Ética SATI Comité de Ética en Investigación; Medical Research Ethics Committees United. Findings will be disseminated in peer review journals and conference presentations.

NCT03963622.

To evaluate the feasibility of conducting a full-scale randomised controlled trial to assess the clinical and cost-effectiveness of the MAINTAIN intervention, designed to support recovery and independence following a fall among people living with dementia.

Pilot cluster randomised controlled trial (c-RCT).

Community-based healthcare services across six UK sites representing primary and secondary care settings.

31 participant-carer dyads were recruited. Eligibility criteria included a diagnosis of dementia and a recent fall. Exclusion criteria included severe comorbidity precluding participation. The consent rate was 84%, and retention at follow-up was 81%.

The MAINTAIN intervention comprised tailored, home-based therapy sessions delivered by trained professionals, focusing on functional recovery, confidence and re-engagement in daily activities, compared with usual care. The intervention was delivered over 12 weeks with booster sessions up to week 24, with the full trial period lasting 28 weeks.

Feasibility outcomes included recruitment and retention rates, intervention adherence and data completeness for outcome and economic measures. Exploratory outcomes assessed functional performance and quality of life. Feasibility outcomes were assessed at baseline, 12 weeks and 28 weeks.

Recruitment occurred over an 8-month period (September 2023–April 2024) across six UK sites. Most intervention participants (89%) attended at least 60% of planned sessions. Completion rates for outcome and economic data were high, indicating strong acceptability and feasibility of both the intervention and trial procedures.

The pilot c-RCT demonstrated that recruitment, retention and intervention delivery were feasible and well accepted. Findings support progression to a definitive trial to evaluate the effectiveness and cost-effectiveness of the MAINTAIN intervention.

ISRCTN16413728 (International Standard Randomised Controlled Trial Number registry).

Young children and children living with HIV are at high risk of progressing to tuberculosis (TB) disease following Mycobacterium tuberculosis (Mtb) exposure and infection, and also of developing severe forms of disease and TB-related mortality. Identifying children who have very early (sub-clinical) TB disease, prior to progression to clinically apparent TB, would mean that TB preventive treatment (TPT) could be more efficiently targeted to this group. Identifying biomarker changes on drug therapy in children with Mtb infection or very early disease could pave the way for the development of tests that can identify which children have viable bacilli and are therefore at increased risk of disease progression.

The INTREPID study will use already collected samples taken from well-phenotyped paediatric cohorts in three clinical studies conducted in South Africa in children Mtb exposure to disease and from children treated for Mtb infection and early TB disease, as well as targeted Mtb antibody analysis. Data on viral co-infections and relevant clinical and epidemiological parameters will be integrated and evaluated to identify the optimal biosignatures that can predict future progression to clinically overt disease in children below 5 years of age, including those living with HIV.

The study protocol received ethical approval from the Stellenbosch University Health Research Ethics Committee (N23/03/025). The study findings will be disseminated through peer-reviewed publications, scientific conferences and formal presentations to healthcare professionals and to local communities, in collaboration with the Desmond Tutu TB Centre Community Advisory Board.

Racialised immigrant communities in Western nations face disproportionate risks for sexually transmitted and blood-borne infections (STBBIs) due to systemic barriers, including racism, stigma and limited access to culturally appropriate care. While the need is well-established, a comprehensive synthesis of effective, culturally responsive sexual health interventions is lacking. This scoping review aims to map the available evidence on sexual health intervention needs and protective factors of racialised immigrants, and to identify and describe existing culturally appropriate programmes in Western nations.

The review will follow the JBI methodology for scoping reviews and be reported as per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) guidelines. A systematic search strategy, developed and peer-reviewed by a health sciences librarian, will be executed in MEDLINE, Embase, CINAHL and Scopus, alongside grey literature sources, with no date limit. Two independent reviewers will screen titles/abstracts and full texts against the inclusion criteria. Data will be extracted using a standardised tool, analysed via narrative synthesis and framed by a socio-ecological model to categorise interventions across individual, interpersonal, community and structural levels.

Ethical approval is not required for this review. Findings will be disseminated through a peer-reviewed publication, academic presentations and tailored summaries for community organisations and policy-makers to ensure practical application.

Open Science Framework (https://osf.io/9qah6).

Recent advances in treatment and care have improved survival rates for children and young adults with severe blood disorders such as sickle cell disease (SCD), transfusion-dependent beta-thalassaemia (TDT) and acute leukaemia. However, their quality of life and reproductive and psychosocial outcomes are not yet well studied. For SCD and TDT, robust survival data are mainly limited to North America. Thus, there is a need to fill these knowledge gaps to guide improvements in care, address unmet clinical needs and rigorously assess the efficacy of emerging novel therapies.

This is an observational population-based mixed-methods study of individuals diagnosed with SCD, TDT or acute leukaemia when under the age of 18 in England, involving a data linkage component and a patient-reported outcomes measures survey. Data linkage-eligible participants will be identified from national and regional databases, including the Hospital Episode Statistics, Yorkshire Specialist Register of Cancer in Children & Young People and the National Congenital Anomaly and Rare Diseases Registration Service. Data linkage will be processed within the NHS England and the University of Leeds’ secure, trusted research environments. Data will be accessed without consent under section 251 and approval by the confidentiality advisory group. It will assess survival rates for SCD and TDT as well as clinical, educational and mental health outcomes for SCD, TDT and acute leukaemia diagnosed in childhood.

Survey-eligible participants for SCD, TDT and acute leukaemia cohorts will be checked for their suitability to participate by the North of England clinical care teams. An NHS-approved survey provider will facilitate data checks with the NHS National Data Opt-Out Service. Consent is required for participation in the survey and for subsequent data linkage to existing databases. Surveys are conducted in various formats (online, paper and phone), with reminders sent after 21 days. The survey will assess quality of life and psychosocial and reproductive outcomes. Participants can withdraw at any time, and support is available via telephone helplines.

The study has received ethical and information governance approval from the Health Research Authority (Reference 24/YH/0186) and the Confidentiality Advisory Group (CAG 24/CAG/0138) to process identifiable data without consent. Study results will be available to patients, physicians, researchers, stakeholders and others through open-access publishing, results sharing via media platforms and presentations at conferences and meetings.

Mothers’ mental health and life satisfaction may have been negatively affected due to challenges during the COVID-19 pandemic. Given the risk of future crises, knowledge of possible mitigating factors in this population is essential. This study aims to examine whether the pandemic affected the level of protective factors such as social support, physical activity and employment situation, and how these factors are associated with mental distress and life satisfaction.

Longitudinal cohort study.

Primary outcomes were mental distress (measured by the eight-item version of the Hopkins Symptom Checklist) and life satisfaction (measured by the Satisfaction With Life Scale). As the first step, we investigated changes in the levels of social support (defined by the number and frequency of social contact), physical activity (average hours of physical activity during a week), employment situation (actively working vs sick leave or unemployed), alcohol consumption (measured by the Alcohol Use Disorders Identification Test-Consumption) and relationship satisfaction (measured by the five-item version of the Relationship Satisfaction Scale).

We analysed data from two waves of the Norwegian Mother, Father and Child Cohort Study (n=~18 000 mothers); one pre-pandemic wave and one wave where half of the sample responded after the onset of the pandemic, with pandemic exposure being defined by questionnaire response timing rather than cohort recruitment. To assess changes in protective factors over time and pandemic exposure, we used difference-in-differences analyses and regression discontinuity design. Associations between protective factors with mental distress and life satisfaction, and possible moderation by pandemic exposure, were investigated using multiple regression models with interaction terms adjusted for potential confounders.

Apart from physical activity, which declined less across time in the pandemic group (B=0.09, 99% CI 0.05 to 0.12), protective factors did not change during the pandemic. Social support, employment situation and relationship satisfaction were associated with mental distress and life satisfaction, whereas physical activity showed a unique relationship with mental distress. Most associations were similar across pandemic exposure groups, except employment situation which appeared to have a stronger protective effect in the pandemic group (β=–0.12, 99% CI –0.24 to –0.00).

Changes over time in self-reported levels of protective factors were generally consistent among mothers independent of the pandemic. These factors appear to play an equally important role for mental distress and life satisfaction both under ordinary circumstances and during public health crises. Our findings enhance the understanding of how potential protective factors among mothers are associated with mental distress and life satisfaction in the context of a global stressor. Future studies should investigate additional mitigating factors that may be particularly relevant during global crises and explore the causal relationship between protective factors, mental health and life satisfaction.

Living labs represent a user-centric approach to solving real-world challenges by encouraging active participation of external stakeholders in co-designing the research and innovation process. Highlighted by contextual research and user co-creation, living labs are ideal for addressing the challenges of providing optimal healthcare to patients living in rural and remote regions. Our objective was to synthesise the existing research on the living lab approach in co-designing, developing or implementing a rural healthcare service, clinical intervention or health-related technology.

Scoping review.

A search was conducted on 10 May 2025, to identify articles from three electronic databases (MEDLINE, EMBASE and CINAHL).

We included published literature that presented a living lab approach to improve the provision of healthcare services in a rural environment. We excluded articles examining social determinants of health (eg, physical activity and general health promotion) without a direct link to clinical service innovation or healthcare delivery.

We collected data on study methodologies, settings, stakeholders and innovation types. Data extraction was performed by two independent reviewers using a standardised form. We used frequencies and a narrative synthesis to map characteristics, methods and contexts of living lab applications in rural healthcare.

The search identified a total of 1080 articles and ultimately included 11 articles. Studies were published between 2016 and 2025 and conducted in Canada (n=3), the USA (n=3), Australia (n=2), Guatemala (n=1), Uganda (n=1) and France/Portugal (n=1). Study settings included rural hospitals, regional health networks, Indigenous communities, farming and fishing communities and underserved rural regions. Health issues targeted included cardiovascular disease, diabetes, musculoskeletal conditions, perinatal care, palliative care and infectious disease management. Study methodologies included formalised, theory-driven frameworks (n=4), community-based participatory research (n=4), user- or human-centred design (n=3) and co-design workshops and interviews (n=3). Only one study explicitly used the term ‘living lab’ to describe their innovation.

Relatively few living lab approaches have been meaningfully applied in rural health. There is a need for greater global diversification, expanded domains of focus and more robust evaluation to fully understand the potential and impact of living labs in rural healthcare.

To assess the feasibility of conducting a cluster randomised controlled trial comparing the effects of Advanced Trauma Life Support (ATLS) and Primary Trauma Care (PTC) with standard care on patient outcomes.

This was a pilot pragmatic three-armed parallel, cluster randomised, controlled trial conducted between April 2022 and February 2023. Patients were followed up for 30 days.

Tertiary care hospitals across metropolitan areas in India.

Adult trauma patients and residents managing these patients were included.

ATLS or PTC training was provided for residents in the intervention arms.

The outcomes were the consent rate, loss to follow-up rate, missing data rates, differences in the distribution between observed data and data extracted from medical records, and the resident pass rate.

Two hospitals were randomised to the ATLS arm, two to the PTC arm and three to the standard care arm. We included 376 patients and 22 residents. The percentage of patients who consented to follow-up was 77% and the percentage of residents who consented to receive training was 100%. The loss to follow-up rate was 14%. The pass rate was 100%. Overall, the amount of missing data for key variables was low. The data collected through observations were similar to data extracted from medical records, but there were more missing values in the extracted data.

Conducting a full-scale cluster randomised controlled trial comparing the effects of ATLS, PTC and standard care on patient outcomes appears feasible, especially if such a trial would use data and outcomes available in medical records.

NCT05417243.

Delays in cancer diagnosis for patients with non-specific symptoms (NSSs) lead to poorer outcomes. Rapid Diagnostic Clinics (RDCs) expedite care, but most NSS patients do not have cancer, highlighting the need for better risk stratification. This study aimed to develop biomarker-based clinical prediction scores to differentiate high-risk and low-risk NSS patients, enabling more targeted diagnostics.

Retrospective and prospective cohort study.

Secondary care RDC in London.

Adult patients attending an RDC between December 2016 and September 2023 were included. External validation used data from another RDC.

The primary outcome was a cancer diagnosis. Biomarker-based risk scores were developed using Latent Class Analysis (LCA) and Least Absolute Shrinkage and Selection Operator (LASSO). Model performance was assessed using logistic regression, receiver operating characteristic curves (AUROC) and decision curve analysis.

Among 5821 RDC patients, LCA identified high white cell count, low haemoglobin, low albumin, high serum lambda light chain, high neutrophil-to-lymphocyte ratio, high serum kappa light chain (SKLC), high erythrocyte sedimentation rate (ESR), high C-reactive protein (CRP) and high neutrophils as cancer risk markers. LASSO selected high platelets, ESR, CRP, SKLC, alkaline phosphatase and lactate dehydrogenase. Each one-point increase in score predicted higher odds of cancer (LCA: AOR 1.19, 95% CI 1.16 to 1.23; LASSO: AOR 1.29, 95% CI 1.25 to 1.34). Scores ≥2 predicted significantly higher cancer odds (LCA: AOR 3.79, 95% CI 2.91 to 4.95; LASSO: AOR 3.44, 95% CI 2.66 to 4.44). Discrimination was good (AUROC: LCA 0.74; LASSO 0.73). External validation in 573 patients confirmed predicted increases in cancer risk per one-point LASSO score rise (AOR 1.28, 95% CI 1.15 to 1.42), with a borderline increase for LCA (AOR 1.16, 95% CI 1.06 to 1.27).

Biomarker-based scores effectively identified NSS patients at higher cancer risk. LCA captured a broader biomarker range, offering higher sensitivity, while LASSO achieved higher specificity with fewer markers. These scores may also help detect severe benign conditions, improving RDC triage. Further validation is needed before broader clinical implementation.

Poor medication adherence is associated with poor clinical outcomes, an increase in hospitalisations and increased mortality. This is a multicentre randomised study that evaluates the effectiveness of using a manual pill organiser (MPO) and a custom-developed pill reminder app (PRA) on medication adherence, morbidity, as well as health economic outcomes among Indian elderly individuals taking multiple medications.

The primary objective of this study is to evaluate the impact of MPO and PRA alone or in combination in improving medication adherence among elderly individuals on multiple medications. The secondary objectives include the impact of interventions on the morbidity profile and health-related quality of life. The study also plans to assess the cost-effectiveness and cost-utility of improving medication adherence.

This is a community-based, open-label, factorial-design randomised controlled trial to be conducted across rural and urban populations at two geographically distinct sites in India. The study will enrol 752 elderly individuals aged 60–80 years, receiving three or more medications for at least 6 months and having access to smartphones. The participants will be randomised to receive one of the following interventions for 12 months: control group, PRA, MPO and MPO+PRA. All study groups would receive patient education about the importance of medication adherence. The study outcomes include the proportion of improvement in medication adherence (using Medication Adherence Rating System-5, 7-day point prevalence of medication non-adherence and pill count); adverse clinical outcomes; healthcare utilisation; health-related quality of life; cost-effectiveness and cost-utility outcomes.

The study protocol has been approved by institutional ethics committees at all three institutes. The study results for primary and secondary outcomes will be published in peer-reviewed journals.

CTRI/2024/01/061975 (Registered on: 29 January 2024).

Post-percutaneous coronary intervention (PCI) fractional flow reserve (FFR) is associated with future major adverse cardiac events and may reflect residual ischaemia and suboptimal stent result (SSR). Post-PCI FFR should therefore be considered to identify patients at high risk. Whether abnormal post-PCI FFR and non-hyperaemic pressure ratios, including resting full-cycle ratio (RFR), represent SSR after PCI remains to be determined, especially after chronic total occlusion (CTO) PCI. In addition, little is known about the association between post-PCI intracoronary physiology and SSR with residual anginal complaints.

The physioLogy to evaluaTe procedural Result After percutaneous coronary intervention of Chronic Total Occlusion study is a prospective, multicentre, exploratory, mechanistic, investigator-initiated, single-arm study with a non-inferiority design. A total of 200 patients, undergoing CTO PCI, with FFR and RFR measured in all patients, will be included at two study sites in the Netherlands. The primary endpoint is the area under the curve (AUC) of post-PCI RFR, in comparison to the AUC of post-PCI FFR, for prediction of optical coherence tomography-detected SSR and its individual components.

The study is approved by the local ethical review board (‘Medisch Ethische Toetsing Commissie Isala Zwolle’). Written informed consent will be obtained from all patients before enrolment. The outcomes of this study are intended to be disseminated in a peer-reviewed journal.

NCT04780971.

As of 2024, 123.2 million people had been forcibly displaced as a result of persecution, armed conflict or climate-related catastrophes, and these numbers are predicted to rise. There is a growing awareness of possible intergenerational effects of trauma on life-course health and well-being, however few studies have followed individuals longitudinally starting prenatally. This paper describes the first large prenatal birth cohort study in a refugee context in a lower middle-income country. This study aims to investigate the potential lifespan health and developmental implications of being born into a protracted humanitarian context, and what factors can buffer from the adversity posed by conflict and displacement.

We outline our approach of recruiting, consenting and gathering data from pregnant Rohingya refugee and host community women (N=2888; 80% Rohingya) over the course of 12 months in Cox’s Bazar, Bangladesh.

A fifth wave of data collection, when children were 6 months old, was completed in April 2025. Rohingya women were substantially less literate; were marrying and having children at slightly younger ages, were more likely to live in crowded, resource-limited households and exhibited higher rates of clinically significant post-traumatic stress disorder and anxiety than host community women.

There is a critical need for research in displaced populations in order to elucidate potentially lasting transgenerational impacts of experiencing conflict and displacement trauma, and the prenatal and postnatal factors that support health and development across the life span. The next follow-up is planned when the children turn 36 months of age (starting March 2026).

Postoperative pulmonary complications (PPCs) are common after cardiac surgery and are associated with significant morbidity and mortality. Lung-protective ventilation strategies have been proposed to reduce PPCs, but the optimal level of positive end-expiratory pressure (PEEP) and the use of alveolar recruitment manoeuvres (RMs) remain controversial.

In this investigator-initiated, multicentre, open, randomised, parallel-group, superiority clinical trial, elective cardiac surgery patients at risk of PPCs will be assigned to one of two intraoperative ventilation strategies: (1) an open-lung ventilation strategy with protective ventilation, moderate PEEP and RMs or (2) a standard protective ventilation with low PEEP and no RM. The primary outcome will be a composite of prolonged (>24 hour) postoperative mechanical ventilation, reintubation for any cause or hospital-acquired pneumonia within 7 days of surgery, or death within 28 days of surgery. Data will be analysed on an intention-to-treat basis.

The VACARM (impact of intraoperatiVe moderAte positive end-expiratory pressure with reCruitment mAnoeuvres versus low positive end-expiRatory pressure on major postoperative pulMonary complications and death after on-pump cardiac surgery in high-risk patients) trial has been approved by an independent ethics committee for all study centres. Recruitment began in July 2021. Results will be published in international peer-reviewed medical journals.

ClinicalTrials.gov NCT04408495.

During the first wave of the COVID-19 pandemic, there was a notable decline in emergency department (ED) usage in many jurisdictions. This study assessed changes in ED use during this period and explored how the pandemic may have aggravated existing healthcare access inequities.

Our primary objective was to assess pandemic-related changes to ED visits and emergency hospitalisations for distinct demographic groups.

We conducted a retrospective observational study using population-based provincial administrative data.

We analysed data from all the 109 EDs and urgent care centres in Alberta, Canada, during the first wave of the COVID-19 pandemic (15 March 2020 to 30 June 2020), and during the corresponding (control) period 1 year earlier. We conducted subgroup analyses by age, First Nations status, sex, location and material deprivation. We repeated all analyses for pre-selected life-threatening emergency diagnoses.

We examined outcomes for a priori subgroups, including female and ‘other’ sex patients, paediatric patients (age 0–17 years), seniors (age 65 years and older), patients living in remote areas (greater than 200 km from an urban centre), First Nations members and patients living in materially deprived postal codes falling into the two most deprived Pampalon Index quintiles.

Primary outcomes were number of ED visits, number of ED visits with admission to hospital and number of ED visits resulting in patient death in the ED. A secondary outcome was change in ED use for life-threatening diagnoses (eg, cardiac conditions and hepatic disease).

ED visits in the COVID-19 period decreased by 34% (Poisson means test p

Reductions in critical emergency care and emergency hospital admissions were unequally distributed across demographic groups during the COVID-19 period. Study methods could be used to monitor and support equitable access to emergency care among distinct populations.

The McMaster Monitoring My Mobility (MacM3) study aims to understand trajectories of mobility decline in later life using multisensor wearable technology. To our knowledge, MacM3 is the first major cohort to combine accelerometry and a Global Positioning System (GPS) to track real-world mobility in community-dwelling older adults.

Between May 2022 and May 2024, MacM3 recruited 1555 community-dwelling older adults (mean age 73.9 years, SD=5.5) from Hamilton and Toronto, Ontario. Of the cohort, 68.4% were female, 62.4% married/partnered, 75.3% had post-secondary education and 62.9% had≥3 comorbidities. Most were Canadian born (69.4%) and white/Caucasian (88.0%), with greater ethnocultural diversity observed at the Toronto site.

At baseline, 56.7% of participants reported no mobility limitations, 15.9% had preclinical limitations and 27.4% had minor mobility limitations. Mean gait speed for the total sample was 1.23 m/s, with a mean Timed Up and Go time of 9.4 s and a 5x sit-to-stand time of 13.0 s. A total of 1301 participants had valid wrist-worn device data, and 1008 participants who agreed to wear the thigh-worn device had valid data (≥7 days with ≥10 hours of wear per day). Step count data (n=1008) revealed a mean of 8437 steps per day (SD=2943), with 5073 steps in the lowest quartile and 12 303 steps in the highest.

Ongoing work aims to develop predictive models of mobility decline by integrating wearable, clinical and environmental data. Pipeline enhancements will enable GPS/inertial measurement unit fusion to explore mobility-environment interactions and support ageing-in-place tools.

Breast cancer is common and women requiring mastectomy will be offered a breast reconstruction if they are surgically suitable candidate. Breast reconstruction can be performed at the same time as the mastectomy (immediate) or delayed to a second operation after cancer treatments. The reconstruction can either use the patients’ own tissue to make the breast (autologous) or use a prosthesis to make the breast in the form of a fixed or expandable volume implant (implant-based breast reconstruction, IBBR). Immediate breast reconstruction on top of the chest wall muscles (prepectoral) is performed worldwide. This operation involves the use of a synthetic or biological mesh placed around the implant under the skin. Increasingly, surgeons are performing this technique without the use of mesh. Both techniques, with and without mesh, have not been compared in a head-to-head randomised controlled trial (RCT); therefore, surgeons and patients do not have high quality data to guide their decision making in this area.

UK-based pragmatic multicentre randomised controlled feasibility trial. The primary aim is to determine the feasibility of a definitive RCT comparing the clinical and cost-effectiveness of no-mesh versus mesh-assisted prepectoral breast reconstruction. Secondary objectives will explore patient understanding of mesh and willingness to be randomised within an RCT; determine if it is possible to collect data to inform a future economic analysis on the use of mesh in breast reconstruction and determine the feasibility of measuring breast biomechanics pre-surgery and post breast reconstruction surgery. Total number of patients to be included: 40 (20 per arm).

This study will be conducted in compliance with the Declaration of Helsinki. Ethical approval has been obtained. Ethics Ref: 23/SC/0302; IRAS Project ID: 301 423. The results of this study will be published in a peer-reviewed medical journal, independent of the results, following the Consolidated Standards of Reporting Trials standards for RCTs.

NCT06112977; ISRCTN17470747.